Rationale Allergen-specific immunotherapy is the only method of treating allergic asthma with long-term effectiveness and potentially, able to change the disease course. The development of a new ...therapeutic vaccine for allergic asthma associated to mite sensitization and effective with few administrations would be a very advantageous alternative.
Rationale Novel therapeutic vaccines for allergic asthma, based on House Dust Mite allergens, effective with fewer administration would be a very advantageous alternative over conventional allergy ...vaccines and would allow a greater extension of the immunotherapy approach, reducing the consumption of symptomatic medications. In Cuba and other Caribbean countries the species Dermatophagoides siboney is very relevant as a cause of respiratory allergy.The objective of this research was to perform the first evaluation in humans of the tolerability and safety of a D. siboney allergen vaccine, adjuvanted with Neisseria meningitidis B proteoliposome (PROLINEM-DS).
Rationale A nasal allergen provocation test (NAPT) is performed to confirm the diagnosis of allergic rhinitis to house dust mite, in the situation of discrepancy between the symptoms and the results ...of skin prick test (SPT) and/or serum specific immunoglobulin E. In Cuba, sensitization to house dust mites (Dermatophagoides pteronyssinus (Dp), Dermatophagoides siboney and Blomia tropicalis) is a major cause of allergic rhinitis. Conclusions Nasal allergen provocation test with the Dermatophagoides pteronyssinus is effective and safety by the diagnosis of allergic rhinitis to this mite.
Sensitization to Blomia tropicalis (Bt) is very frequent in the tropics, and particularly in Cuba, being a significant cause of allergic asthma. Allergen immunotherapy (AIT) with Bt can be a ...therapeutic option, however, placebo-controlled clinical trials have not been reported.
To assess the therapeutic effect and safety of AIT for asthma using a standardized allergen vaccine of B. tropicalis by subcutaneous route, in allergic asthmatic patients exposed and sensitized to this mite species.
A double-blind, placebo-controlled Phase II trial was conducted in 35 adults (18 with treatment and 17 with placebo), with mild to moderate asthma, predominantly sensitized to Bt. AIT was administered subcutaneously in increasing doses from 4 to 6000 Biological Units using a locally manufactured standardized extract (BIOCEN, Cuba). Patient assessment was performed using symptom-medication score (SMS), peak expiratory flow and skin reactivity relative to Histamine as measured by skin prick test (SPT).
The 12-month treatment achieved a significant (p < 0.001) decrease of SMS. Symptom score showed only 41% (CI: 26–61) of placebo values, whereas medication was 34.5% (22.4%–63.3%). Treatment was regarded clinically effective in 67% of patients (OR 32; 95%CI: 17 to 102). The effect size on symptoms and medication was higher than has been reported with equivalent allergen dosages of D. pteronyssinus and D. siboney in Cuban asthmatic patients. Skin reactivity to Bt was also significantly reduced (p = 0.0001), increasing 148-fold the allergen threshold to elicit a positive skin test. This desensitization effect was specific to Bt and did not modify the reactivity to Dermatophagoides. The change of specific skin reactivity was significantly (p < 0.05) correlated to clinical improvement. All adverse events were local with a frequency of 2.4% of injections.
Subcutaneous AIT with Blomia tropicalis was effective and safe in asthmatic adults exposed and sensitized to this mite species in a tropical environment.
Cuban Public Registry of Clinical Trials: RPCEC00000026 (WHO International Clinical Trial Registry Platform ICTRP).
El Centro Nacional de Biopreparados, entidad de ciencia y tecnología integrada a las acciones del Estado para la actualización del modelo económico, asume nuevos retos ante la COVID-19 en su ...actividad de ciencia e innovación. En solo 10 semanas se desarrolló y registró un medio de transporte para SARS-CoV-2; se introdujo en los protocolos de prevención la aplicación de Biomodulina T® con más de 10 000 adultos mayores tratados, sin que ninguno haya adquirido la enfermedad; se introdujeron dos nuevos medicamentos derivados de la investigación, y se entregaron 2,8 millones de unidades de otros ocho productos. Los principales elementos dinamizadores de la generación de productos innovadores fueron adaptados a las nuevas condiciones, especialmente la gestión del capital humano altamente calificado y motivado, el aprovechamiento más intensivo de las capacidades productivas y analíticas, cumpliendo con los elevados estándares regulatorios, la estructura empresarial, el sistema logístico y la gestión comercial.
Nasal provocation test (NPT) is indicated to confirm the diagnosis of allergic rhinitis to house dust mites. Methods An open, non-randomized, controlled clinical trial was carried out in 50 patients ...with allergic rhinitis sensitized to D. siboney mite and 50 non-allergicsubjects.
RESUMEN Introducción: Los medios de colecta de muestras clínicas con capacidad de desnaturalizar virus reducen los riesgos de contagio durante el transporte y procesamiento. Objetivo: Emplear el ...medio de transporte de ácidos nucleicos (TAN) en muestras de exudado nasofaríngeo colectadas para el diagnóstico de SARS-CoV-2. Métodos: Se realizó un estudio experimental para demostrar la capacidad del medio de inactivar la infectividad viral. Se tomó como modelo de virus envuelto el virus Zika (VZk), cuyo nivel de bioseguridad es 2. Se evaluó el desempeño clínico del medio TAN para el diagnóstico de SARS-CoV-2. Se empleó una cepa del VZk propagada en la línea celular Vero y, previo a la infección de las células, el VZk se puso en contacto a intervalos de tiempo diferentes (2; 15 y 30 min) con el medio TAN puro; y luego se realizaron diluciones seriadas (10-1-10-4). La inactivación viral se evaluó por RT-PCR, en el sobrenadante y células colectadas, al culminar el periodo de propagación. El desempeño clínico del medio TAN se estimó tomando como referencia el CITOSWAB® VTM, en 30 exudados nasofaríngeos colectados para diagnóstico de la infección por SARS-CoV-2. Resultados: El VZk preservó su infectividad a diluciones del inóculo ≥ 10-2, independientemente del tiempo de contacto. La sensibilidad y especificidad clínica del medio TAN para el diagnóstico de SARS-CoV-2 fueron del 100 %, respectivamente. Conclusiones: Los resultados sugieren que muestras clínicas positivas a VZk en diluciones ≤ 10-1 del medio TAN pueden ser manipuladas de forma segura, lo que pudiera aplicarse potencialmente al diagnóstico molecular del SARS-CoV-2.
Most Latin-American countries use subcutaneous immunotherapy (SCIT) extracts from the United States and Europe and sublingual immunotherapy (SLIT) from Europe, with the exception of Argentina, ...Brazil, Cuba and Mexico. The number of researches on immunotherapy (IT) in Latin America has increased extensively in the last years. Only few Latin American countries have their own guidelines on IT, and, in general, the economic resources for medical research on IT are still low in the area. A global approach for the future of IT in Latin America includes to improve standardization, quality control and the production of allergen products, to develop IT guidelines and clinical investigation by the highest number of countries, to improve the regulatory status for allergens products in the area, and to expand IT accessibility for low-income patients. In Cuba, the first registered allergen vaccines were developed and registered in 2006: a standardized (in biologic units) and freeze dried product for SCIT, with a sublingual version developed in 2009. As much as 23.000 IT treatments were applied in 2011, all provided to patients free of charge. In 2012, Cuban researchers developed an IT vaccine with adjuvant for subcutaneous route, which uses Neisseria meningitidis proteoliposome as an adjuvant, added to the purified Dermatophagoides siboney major allergens: Der s1 and Der s2. Since December 2012, this vaccine is in Phase I clinical trial, evaluating its safety, tolerability and immunogenicity in asthmatic patients sensitized to this allergen. Cuban perspectives on IT includes to work on new indications for IT, to investigate the preventive effect and cost-effectiveness for the current vaccines, to develop new products with mixed formulas of house dust mites for SLIT, to complete the phase I and II clinical study for dust mite plus adjuvant vaccine, to develop allergen vaccines for fungi allergy and to complete the Cuban guideline for allergen IT management.
Peanut allergy is increasing at an alarming pace in developed countries. Peanut (
) is a common food in Cuba. Nevertheless, reported values of sensitization and symptom severity are usually low. As ...our objective, we carried out an evaluation of allergic sensitivity to perform an assessment of allergic sensitization and IgE specificity profile to peanut allergens in Cuban allergic patients.
The Skin Prick Test (SPT) was performed for each patient, using two glycerinated allergenic extracts, prepared from raw or roasted peanuts. Overall, 316 food allergic patients (159 adults and 157 children) attending allergy services at four hospitals in Havana were included, as well as 303 adult non- allergic volunteers. The IgE binding profile of 26 selected SPT positive patients was further analyzed by immunoblotting.
The prevalence of sensitization to peanut was 4.6% in general adult population, whereas in adult food-allergic patients it was 18.6%. Prevalence rates were even greater in food allergic children achieving 25.8%. Sensitization frequencies were apparently greater for roasted, as compared to raw peanuts, although the difference was not significant (
> 0.05, Mc Nemar's). IgE binding was shown mostly by the 15 and 17 kDa bands, tentatively identified as the major allergens Ara h 2 and Ara h 6. The IgG4 binding profile was similar to IgE, although with more prominence of the bands at 37 and 28 KDa, corresponding to an Ara h 3 fragment and Peanut Agglutinin.
The study estimated a relatively high prevalence of peanut sensitization in population. Data reported here suggest that IgE sensitization in Cuban patients is focused mostly on MW bands corresponding to the major allergens Ara h 6 and Ara h 2.
Sensitization to peanut allergen is indeed relatively frequent in Cuba. The IgE profile is congruent to a sensitization pattern by ingestion of roasted peanuts and is directed to well-known major allergens.
Occupational allergies are becoming more frequent. The allergens present in the working environment of bakeries, such as mites, are not well identified despite being known risk factors of respiratory ...diseases.
To isolate and identify the species of mites present in two bakeries in La Habana, Cuba, with high sensitization of mites on their workers.
A descriptive study was done in which samples were taken by tripled from potential sources of mites in bakeries -as flourin use, spills of wheat on the floors, wheat flour stored in sealed bags, sugar, yeast, granulated baker- that were processed, according to the method of flotation of Hart and Fain (1987) to isolate, identify and count the mites present.
Mites were found in samples of wheat flourin use, spills on the floorsand in the wheat flourstored in sealed bags. The species identified were Blomia tropicalis (70%), Tyrophagus putrescentiae (20%) and to a lesser degree Dermatophagoides pteronyssinus and Dermatophagoides siboney.
There is a high exposure to house dust mites, particularly to store mites, which constitute a risk factor of occupational allergy to consider.
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